Dragonfly-M Early Feasibility Study

NCT04528576 | Unknown

• 1 other identifier: DragonFly-M-2020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To establish the safety and effectiveness of the DragonFly transcatheter mitral valve repair system in symptomatic patients with moderate to severe and severe mitral regurgitation who have been determined to be at an high risk of mortality with mitral valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Conditions

Mitral Regurgitation

Keywords

mitral regurgitation; TMVr

Outcome Measures

Primary Outcomes (2)

• Incidence of acute procedural success

  The acute procedural success is defined as successful Dragonfly implantation, and residual MR of 2+ or less at discharge. An echocardiogram at 30 days can be accepted if the discharge image was not available or hard to interpret. A death before discharge or a re-operation of mitral valve prior to 30 days is defined as acute procedure failure

  1 month

• Incidence of major adverse event (MAE) at 30 days

  Major adverse event is defined as one of the following components: death, myocardial infarction (MI), stroke, renal failure requiring dialysis, and cardiac surgery for Dragonfly device failure.

  1 month

Secondary Outcomes (6)

• All-cause mortality

  6 months

• Cardiovascular mortality

  6 months

• Incidence of serious adverse event (SAE）

  6 months

• NYHA

  6 months

• Technical success

  Immediately after procedure

Study Arms (1)

DragonFly-M

EXPERIMENTAL

Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Meditech Co., Ltd

Device: Dragonfly mitral valve repair system

Interventions

Dragonfly mitral valve repair system DEVICE

With transesophageal echocardiographic guidance,implanting clip using Dragonfly mitral valve repair system

DragonFly-M

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 yrs
• Moderate-to-severe (3+) or severe (4+) mitral valve regurgitation on transthoracic or transesophageal echocardiography, and confirmed by echocardiographic core laboratory
• The patient is on optimal guideline directed medical therapy for heart failure and remains symptomatic.
• High or prohibitive surgical risk as defined by either Society for Thoracic Surgery Risk Calculator score for valve replacement ≥ 8 points; or STS score for valve repair ≥ 6 points , prohibitive risk as determined by the clinical judgement of the site heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experience in mitral valve disease, due to the presence of one or more documented surgical risk factors.
• Anatomically suitable for mitral valve repair and can be treated by Dragonfly confirmed by both site investigators, echocardiographic core laboratory, and the eligibility committee.
• Transseptal catheterization and femoral vein access is determined to be feasible
• Life expectancy ≥ 12 months
• The subject or the subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests and follow-ups, and has provided written informed consent

You may not qualify if:

• History of heart transplantation, prior mitral valve replacement surgery. or transcatheter mitral valve procedure;
• Leaflet anatomy which may preclude Dragonfly-MTM implantation and position, as judged by the site investigators and confirmed by the echocardiographic core laboratory and eligibility committee
• Evidence of calcification or significant cleft in the grasping area
• LVEF \< 20%
• LVESD≥ 60mm;
• Mobile leaflet length\<10mm
• Mitral valve effective orifice area (EOA) \< 3.5cm2 or in the opinion of site investigators and confirmed by the echocardiographic core laboratory and eligibility committee that mitral stenosis would result from implantation of the Dragonfly-MTM device.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
• Severe non-mitral valve disease requiring treatment .
• Severe pulmonary artery hypertension (sPAP\>70mmHg)
• Severe right ventricular dysfunction;
• Active endocarditis or previous mitral valve endocarditis; Active rheumatic heart disease or leaflets degenerated from rheumatic disease
• Severe untreated coronary artery stenosis requiring revascularization; or with other cardiovascular disease requiring surgical treatment；
• Extreme frailty
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis and any other structural heart disease causing heart failure other than dilated cardiomyopathy;

Sponsors & Collaborators

• Hangzhou Valgen Medtech Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Liu X, Chen M, Han Y, Pu Z, Lin X, Feng Y, Xu K, Lam YY, Lim DS, Wang J. First-in-Human Study of the Novel Transcatheter Mitral Valve Repair System for Mitral Regurgitation. JACC Asia. 2022 Jun 21;2(3):390-394. doi: 10.1016/j.jacasi.2022.03.010. eCollection 2022 Jun.

  PMID: 36338402 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• jianan Wang, PhD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The clinical trial was designed as a single group assignment study. The participants with moderate to severe and severe mitral valve regurgitation will receive a transseptal mitral valve repair using Dragonfly mitral valve repair system.

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 27, 2020
• Study Start: July 23, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 29, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)